Medical device with hemostatic valve

ABSTRACT

In various examples, a hub for a medical device includes a hub housing including a passage from a proximal end of the hub housing to a distal end of the hub housing. A valve is disposed within the hub. The valve is configured to allow passage of an insertable device through the valve while inhibiting leakage of fluid from the valve. A cap is engaged to the hub housing. The cap includes an opening therethrough sized and shaped to allow passage of the insertable device through the opening. The opening allows access to the passage of the hub housing. An angled sidewall is disposed within the hub. The angled sidewall is configured to retain and deform the valve into a curved shape.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of priority to U.S. ProvisionalApplication Ser. No. 62/501,801, filed on May 5, 2017, entitled “CAPRETENTION FEATURES FOR HEMOSTATIC VALVE,” and U.S. ProvisionalApplication Ser. No. 62/501,876, filed on May 5, 2017, entitled“OVERMOLDED HUB ON EFEP,” each of which is each incorporated byreference herein in its entirety.

BACKGROUND

The present invention relates to a medical device, and more specificallyrelates to a medical device including a hemostatic valve configured toinhibit fluid leakage from the medical device.

When inserting a device, such as a catheter, introducer, or other accessdevice, within a patient, fluid of a higher pressure can be experiencedwithin the patient, and in turn, the device, than is experienced inatmospheric conditions external to the device and the patient. This isparticularly true with insertion of the device within an artery. Such apressure differential can often lead to fluid leaking, spraying, orotherwise exiting from the device, which is typically not a desirableperformance characteristic of such a device.

Overview

This overview is intended to provide an overview of subject matter ofthe present patent document. It is not intended to provide an exclusiveor exhaustive explanation of the invention. The detailed description isincluded to provide further information about the present patentdocument.

The present inventors have recognized, among other things, that thepresent subject matter can be used to inhibit leakage from a medicaldevice, such as, for instance, a catheter, a sheath, an introducer, orother access device. In various examples, the present subject matter isadvantageous in that it provides increased responsiveness in sealing ahemostatic valve, thereby inhibiting spraying and excessive leaking fromthe valve. The present inventors have recognized the present subjectmatter can allow for a medical device including a thinner valve, therebyleading to reduced insertion force when inserting an instrument, device,or other object through the valve. Also, the present subject matter isadvantageous in that it provides for improved manufacturing of a medicaldevice including a hemostatic valve. To better illustrate the devicesdescribed herein, a non-limiting list of examples is provided here:

Example 1 can include subject matter that can include a hub for amedical device. The hub includes a hub housing including a passage froma proximal end of the hub housing to a distal end of the hub housing. Avalve is disposed within the hub. The valve is configured to allowpassage of an insertable device through the valve while inhibitingleakage of fluid from the valve. A cap is engaged to the hub housing.The cap includes an opening therethrough sized and shaped to allowpassage of the insertable device through the opening. The opening allowsaccess to the passage of the hub housing. An angled sidewall is disposedwithin the hub. The angled sidewall is configured to retain and deformthe valve into a curved shape.

In Example 2, the subject matter of Example 1 is optionally configuredsuch that the angled sidewall forms a tapered ring sized to accept thevalve within the tapered ring.

In Example 3, the subject matter of Example 2 is optionally configuredsuch that the tapered ring includes a first diameter at a proximal sideof the tapered ring and a second diameter at a distal side of thetapered ring, the first diameter being smaller than the second diameter.

In Example 4, the subject matter of any one of Examples 1-3 isoptionally configured such that the angled sidewall is configured todeform the valve into a substantially concave shape when viewed from aproximal side.

In Example 5, the subject matter of any one of Examples 1-4 isoptionally configured such that the cap includes the angled sidewall.

In Example 6, the subject matter of any one of Examples 1-5 optionallyincludes a pressure ring disposed between the cap and the valve. Thepressure ring includes a pressure ring opening that is smaller than theopening of the cap, wherein a distal side of the pressure ring is shapedto abut a first proximal side of the valve.

In Example 7, the subject matter of any one of Examples 1-6 isoptionally combined with a sheath extending distally from the distal endof the hub housing. The sheath includes a lumen through the sheath. Thelumen is fluidly coupled to the passage of the hub housing.

In Example 8, the subject matter of Example 7 is optionally configuredsuch that the sheath is at least partially formed from EFEP.

In Example 9, the subject matter of any one of Examples 7-8 isoptionally configured such that the sheath is overmolded with the hubhousing.

Example 10 can include, or can optionally be combined with any one ofExamples 1-9 to include subject matter that can include a medicaldevice. A hub includes a hub housing including a passage from a proximalend of the hub housing to a distal end of the hub housing. A valve isdisposed within the hub. The valve is configured to allow passage of aninsertable device through the valve while inhibiting leakage of fluidfrom the valve. A cap is engaged to the hub housing. The cap includes anopening therethrough sized and shaped to allow passage of the insertabledevice through the opening. The opening allows access to the passage ofthe hub housing. An angled sidewall is disposed within the hub. Theangled sidewall is configured to retain and deform the valve into acurved shape. A sheath extends distally from the distal end of the hubhousing. The sheath includes a lumen through the sheath. The lumen isfluidly coupled to the passage of the hub housing.

In Example 11, the subject matter of Example 10 is optionally configuredsuch that the angled sidewall forms a tapered ring sized to accept thevalve within the tapered ring.

In Example 12, the subject matter of Example 11 is optionally configuredsuch that the tapered ring includes a first diameter at a proximal sideof the tapered ring and a second diameter at a distal side of thetapered ring, the first diameter being smaller than the second diameter.

In Example 13, the subject matter of any one of Examples 10-12 isoptionally configured such that the angled sidewall is configured todeform the valve into a substantially concave shape when viewed from aproximal side.

In Example 14, the subject matter of any one of Examples 10-13 isoptionally configured such that the cap includes the angled sidewall.

In Example 15, the subject matter of any one of Examples 10-14 isoptionally configured such that the valve includes at least one slitwithin the valve. The slit extends from a first proximal side of thevalve to a second distal side of the valve. The slit is angularlyrotated within the valve from the first proximal side to the seconddistal side.

In Example 16, the subject matter of any one of Examples 10-15 isoptionally configured such that the at least one slit includes at leasttwo intersecting slits within the valve.

In Example 17, the subject matter of any one of Examples 10-16 isoptionally configured such that the valve includes a first slit and asecond slit. The first slit extends partially through the valve from afirst proximal side of the valve. The second slit extends partiallythrough the valve from a second distal side of the valve. The secondslit is angularly offset from the first slit. The first and second slitsintersect at a location within the valve intermediate the first proximalside and the second distal side.

In Example 18, the subject matter of any one of Examples 10-17optionally includes a pressure ring disposed between the cap and thevalve. The pressure ring includes a pressure ring opening that issmaller than the opening of the cap, wherein a distal side of thepressure ring is shaped to abut a first proximal side of the valve.

In Example 19, the subject matter of any one of Examples 10-18 isoptionally configured such that the sheath is at least partially formedfrom EFEP.

In Example 20, the subject matter of any one of Examples 10-19 isoptionally configured such that the sheath is overmolded with the hubhousing.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a perspective view of a medical device in accordance with atleast one example of the invention.

FIG. 1B is a side view of a medical device in accordance with at leastone example of the invention.

FIG. 1C is a top view of a medical device in accordance with at leastone example of the invention.

FIG. 1D is a cross-sectional view of the medical device of FIG. 1B takenalong line 1D-1D.

FIG. 2A is a top view of a cap of a medical device in accordance with atleast one example of the invention.

FIG. 2B is a bottom view of a cap of a medical device in accordance withat least one example of the invention.

FIG. 2C is a side view of a cap of a medical device in accordance withat least one example of the invention.

FIG. 2D is a cross-sectional view of the cap of FIG. 2C taken along line2D-2D.

FIG. 2E is an enlarged view of a portion 2E of the cap of FIG. 2D.

FIG. 2F is a perspective view of a cap of a medical device in accordancewith at least one example of the invention.

FIG. 3A is a top view of a valve of a medical device in accordance withat least one example of the invention.

FIG. 3B is a side view of a valve of a medical device in accordance withat least one example of the invention.

FIG. 3C is a perspective view of a valve of a medical device inaccordance with at least one example of the invention.

FIG. 4A is a top view of a valve of a medical device in accordance withat least one example of the invention.

FIG. 4B is a cross-sectional view of the valve of FIG. 4A taken alongline 4B-4B.

FIG. 4C is a cross-sectional view of the valve of FIG. 4A taken alongline 4C-4C.

FIG. 4D is a perspective view of a valve of a medical device inaccordance with at least one example of the invention.

FIG. 5A is a perspective view of a medical device in accordance with atleast one example of the invention.

FIG. 5B is a side view of a medical device in accordance with at leastone example of the invention.

FIG. 5C is a top view of a medical device in accordance with at leastone example of the invention.

FIG. 5D is a cross-sectional view of the medical device of FIG. 5B takenalong line 5D-5D.

FIG. 6A is a top view of a cap of a medical device in accordance with atleast one example of the invention.

FIG. 6B is a bottom view of a cap of a medical device in accordance withat least one example of the invention.

FIG. 6C is a side view of a cap of a medical device in accordance withat least one example of the invention.

FIG. 6D is a cross-sectional view of the cap of FIG. 6C taken along line6D-6D.

FIG. 6E is an enlarged view of a portion 6E of the cap of FIG. 6D.

FIG. 6F is a perspective view of a cap of a medical device in accordancewith at least one example of the invention.

FIG. 7A is a top view of a pressure ring of a medical device inaccordance with at least one example of the invention.

FIG. 7B is a cross-sectional view of the pressure ring of FIG. 7A takenalong line 7B-7B.

FIG. 7C is a side view of a pressure ring of a medical device inaccordance with at least one example of the invention.

FIG. 7D is a perspective view of a pressure ring of a medical device inaccordance with at least one example of the invention.

DETAILED DESCRIPTION

The present patent application relates to a medical device, and morespecifically relates to a medical device including a valve configured toinhibit fluid leakage from the medical device. In various examples, asdescribed herein, the medical device can include various introducers,catheters, sheaths, and/or other access devices including a hemostaticvalve configured to allow insertion of a device, instrument, or otherobject through the valve while inhibiting fluid leakage from the valve.

Referring to FIGS. 1A-1D and 5A-5D, in various examples, a medicaldevice 100, 100′ includes a hemostatic valve in order to inhibit, if noteliminate, fluid leakage from the medical device 100, 100′, forinstance, when the medical device 100, 100′ is at least partiallyinserted within a patient. In some examples, the medical device 100,100′ is configured to inhibit fluid leakage from the medical device 100,100′ with the medical device 100, 100′ at least partially insertedwithin vasculature of the patient. In further examples, the medicaldevice 100, 100′ is configured to inhibit fluid leakage from the medicaldevice 100, 100′ with the medical device 100, 100′ at least partiallyinserted within an artery of the patient. In various examples, themedical device 100, 100′ includes an introducer, a sheath, a catheter,or other access device. In other examples, the medical device 100, 100′can include any device for which a pressure differential is presentbetween inside of the medical device 100, 100′ and outside of themedical device 100, 100′, for instance, when the medical device 100,100′ is at least partially inserted within the patient.

The example medical devices 100, 100′ shown in FIGS. 1A-1D and 5A-5Dinclude introducers which are each shown as including a side port 170.The side port 170, in some examples, allows for introduction of a fluid,such as saline, for instance, into the medical device 100, 100′. Inother examples, a gas can be introduced into the medical device 100,100′ using the side port 170. In some examples, a pressure source can befluidly coupled to the medical device 100, 100′ using the side port 170.In some examples, a negative pressure can be introduced to the medicaldevice 100, 100′ using the side port 170, for instance to suction orotherwise remove fluid, gas, or other materials from within the medicaldevice 100, 100′ and/or the patient. In other examples, a positivepressure can be introduced to the medical device 100, 100′ using theside port 170, for instance to inflate a cavity of the patient.

In some examples, the side port 170 includes a tube 172 or other conduitfluidly coupled to a hub 110, 110′ of the medical device 100, 100′ at aside port opening 124. In some examples, the side port includes astopcock 174 or other valve configured to allow fluid coupling of one ormore inlets 174A, 174B to an outlet 174C of the stop cock 174. Althoughshown with two inlets 174A, 174B, in other examples, the stopcock 174can include fewer or more than two inlets 174A, 174B, depending on thedesired application and/or requirements for the procedure to beperformed using the medical device 100, 100′. The outlet 174C, in someexamples, is fluidly coupled to the tube 172 or other conduit. In someexamples, the stopcock 174 includes a handle 176 that is rotatable orotherwise actuatable in order to fluidly couple one or more of theinlets 174A, 174B to the outlet 174C and, in turn, the hub 110, 110′ ofthe medical device 100, 100′. In this way, a fluid source and/or apressure source can be coupled to one or more of the inlets 174A, 174Bwith the handle 176 being used to select which, if any, of the one ormore inlets 174A, 174B to fluidly couple with the hub 110, 110′ of themedical device 100, 100′. Although shown as including the side port 170,this is not intended to be limiting. That is, in some examples, thepresent subject matter can be used with a medical device that does notinclude a side port. While various exemplary devices are shown anddescribed herein, these are merely exemplary and should not beconsidered limiting.

Referring now to FIGS. 1A-1D, in some examples, the medical device 100includes the hub 110. In some examples, the hub 110 includes a hubhousing 120 including a passage 122 from a proximal end 120A of the hubhousing 120 to a distal end 120B of the hub housing 120. In someexamples, the hub housing 120 includes the side port opening 124 forattachment to the tube 172 or other conduit of the side port 170. Insome examples, the side port opening 124 is fluidly coupled to thepassage 122 within the hub housing 120. In some examples, the hub 110includes a valve 130, 130′ disposed within the hub 110. The valve 130,130′, which is described in greater detail below, is configured, in someexamples, to allow passage of an insertable device through the valve130, 130′ while inhibiting leakage of fluid from the valve 130, 130′. Invarious examples, various insertable devices are contemplated for usewith the medical device 100, including, but not limited to, a guidewire,a catheter, an introducer, a sheath, a dilator, or other instrument,tool, or device. In some examples, a cap 140 is engaged to the hubhousing 120. In some examples, the cap 140 includes an opening 142therethrough sized and shaped to allow passage of the insertable devicethrough the opening 142. In some examples, the opening 142 allows accessto the passage 122 of the hub housing 120, such that, with insertion ofthe insertable device through the opening 142 of the cap 140, theinsertable device can be further moved distally to enter the passage 122within the hub housing 120. An angled sidewall 144, in some examples, isdisposed within the hub 110, the angled sidewall 144 being configured toretain and deform the valve 130, 130′ into a curved shape.

In some examples, the cap 140 and the hub housing 120 of the hub 110 areeach formed from a polymeric material. In some examples, the cap 140 andthe hub housing 120 can be formed from the same material, while, inother examples, the cap 140 and the hub housing 120 can be formed fromdifferent materials. In some examples, the cap 140 and/or the hubhousing 120 are/is formed from nylon. In other examples, the cap 140and/or the hub housing 120 are/is formed fromacrylonitrile-butadiene-styrene (ABS).

In some examples, a sheath 160 extends distally from the distal end 120Bof the hub housing 120. The sheath 160, in some examples, includes alumen 162 through the sheath 160. In some examples, the lumen 162 isfluidly coupled to the passage 122 of the hub housing 120. In this way,an insertable device can be passed through the valve 130, 130′, into thepassage 122, through the lumen 162, and out of a distal end 160B of thesheath 160 in order to access a location within the patient with theinsertable device. In some examples, the sheath 160 includes a proximalend 160A that is partially disposed within the passage 122 of the hubhousing 120. In some examples, the sheath 160 is overmolded with the hubhousing 120. In further examples, the hub housing 120 is overmolded tothe proximal end 160A of the sheath 160. In some examples, the sheath160 is at least partially formed fromethylene-tetrafluoroethylene-hexafluoropropylene-fluoroterpolymer(EFEP). In some examples, the hub housing 120 is at least partiallyformed from nylon. In some examples, the hub housing 120 is at leastpartially formed from acrylonitrile-butadiene-styrene (ABS). In someexamples, the EFEP material includes properties that facilitateovermolding of the EFEP material and the hub housing 120. That is, arelatively low processing temperature of the EFEP material allows forincreased adhesion when overmolded. In some examples, the meltingtemperature of the EFEP material is significantly lower than othermaterials contemplated for use in forming the tubing, such as, but notlimited to, fluorinated ethylene propylene (FEP) and ethylenetetrafluoroethylene (ETFE).

In some examples, EFEP can include mechanical properties that aredesirable for the manufacture and/or function of the medical device 100.In some examples, the use of EFEP for the sheath 160 allows for simplerand cheaper processes to produce the medical device 100, leading todecreased manufacture time and expense than would otherwise be expectedwith a medical device formed using a material other than EFEP for asheath. In some examples, the use of EFEP gives flexibility and columnstrength similar to that of FEP or ETFE but lower meltingcharacteristics lends to better adhesion when overmolded.

In some examples, the medical device 100 includes the sheath 160 formedfrom EFEP, the sheath 160 being etched at the proximal end 160A andovermolded with the hub housing 120. In some examples, the EFEP of thesheath 160 can be chemically etched to improve and/or strengthen bondingbetween the sheath 160 and the hub housing 120, for instance, toincrease tensile and liquid performance. In some examples, the EFEP ofthe sheath 160 includes a sodium napthalene chemical etch. In someexamples, the sheath 160 can be overmolded to the hub housing 120without the sheath 160 being etched. In some examples, the sheath 160can include a thermoformed tip at the distal end 160B. In some examples,a length of the sheath 160 can be coated with a lubricious hydrophiliccoating.

In some examples, the sheath 160, for instance, formed from EFEP, can beformed with a relatively thin wall, due to, at least in part, mechanicalproperties of the EFEP material, such as, but not limited to, columnstrength and kink properties. In some examples, the sheath 160 can beformed with a wall thickness of 0.010 inches or less. In furtherexamples, the sheath 160 can be formed with a wall thickness of 0.005inches. Having a thinner wall, in some examples, allows for a reductionin outer diameter of the sheath 160 while still maintaining an innerdiameter sufficient to pass various insertable devices, including, butnot limited to instruments, devices, or the like, through the medicaldevice 100. This allows for a physician or other user to make a smallerincision in the patient receiving the medical device 100, therebyallowing for an easier and/or less traumatic experience for the patient.In some examples, the sheath 160 formed from EFEP can allow for thesheath 160 of the medical device 100 to include an outer diameter thatis similar to other introducers but with a larger inner diameter,thereby allowing for larger insertable devices, instruments, or otherdevices to be passed through the medical device 100.

In some examples, the medical device 100 includes a strain relief member150 configured to reduce kinking, tearing, and/or excessive bending ofthe sheath 160, particularly in the area of where the sheath 160 extendsfrom the hub housing 120. In some examples, the strain relief member 150is configured to limit the amount of bending of the sheath 160 proximateto the hub housing 120. In some examples, the strain relief member 150allows for flexibility in the sheath 160 while minimizing stress on thesheath 160, particularly in the area of the sheath 160 proximate wherethe sheath 160 extends from the hub housing 120, which is oftentimes alocation of the sheath 160 that is vulnerable to excessive bending,kinking, and/or tearing or other breakage. In some examples, the strainrelief member 150 includes a resilient material. In further examples,the strain relief member 150 is formed from one or more resilientmaterials. For instance, in some examples, the strain relief member 150is at least partially formed from a thermoplastic elastomer (TPE).

In some examples, the strain relief member 150 is engageable with thehub housing 120. In some examples, the strain relief member 150 isrotatably engageable with the hub housing 120. In various examples, thestrain relief member 150 can be engaged with the hub housing 120 indifferent ways, including, but not limited to, a snap fit, a frictionalengagement, being attached with adhesive, being attached with one ormore fasteners, a bayonet connection, a tab-in-slot connection, or acombination thereof. For instance, in the example shown in FIG. 1D, thestrain relief member 150 is snap fit to the hub housing 120. In thisexample, the hub housing 120 includes a ridge 126 proximate the distalend 120B of the hub housing 120, and the strain relief member 150includes a channel 156 sized and shaped to accept the ridge 126 of thehub housing within the channel 156. In some examples, the resilientnature of the strain relief member 150 allows for the strain reliefmember 150 to temporarily deform to allow the strain relief member 150to be passed over the ridge 126 of the hub housing 120 to place theridge 126 within the channel 156 of the strain relief member 150,thereby attaching the strain relief member 150 to the hub housing 120.In some examples, the strain relief member 150 is formed from a materialthat is soft to the touch. In some examples, the strain relief member150 is rotatable with respect to the hub housing 120. For instance, insome examples, the strain relief member 150 can be relatively looselyattached to the hub housing 120 to allow for the strain relief member150 to rotate with respect to the hub housing 120. In other examples,however, the strain relief member 150 can be relatively tightly attachedto the hub housing 120, thereby inhibiting rotation of the strain reliefmember 150, if desired.

In some examples, the strain relief member 150 includes a tab 152extending outwardly from the strain relief member 150. In furtherexamples, the tab 152 can include a suture hole 154 through the tab toallow for the medical device 100 to be attached to the patient and/oranother object using one or more sutures through the suture hole 154. Insome examples, it can be desirable for the strain relief member 150 tobe rotatable with respect to the hub housing 120 to allow for rotationof the tab 152 and, in turn, the suture hole 154, to allow foradjustment of the tab 152 and the suture hole 154 for proper positioningof the suture hole 154 with respect to the patient and/or other objectprior to suturing of the medical device 100 to the patient and/or otherobject.

Referring now to FIGS. 1A-2F, the medical device 100 includes the angledsidewall 144 configured to accept and retain the valve 130, 130′ withinthe angled sidewall 144. In some examples, the angled sidewall 144 caninclude discrete segments formed around the area within which the valve130, 130′ is to be positioned. In other examples, the angled sidewall144 forms a tapered ring sized to accept the valve 130, 130′ within thetapered ring. In some examples, the cap 140 includes the angled sidewall144. In some examples, the angled sidewall 144 is integrally formed aspart of the cap 140. In other examples, the hub housing can include theangled sidewall.

In some examples, the angled sidewall 144 is configured to compress thevalve 130, 130′ in order to retain the valve 130, 130′ within the angledsidewall 144, effectively pinching the valve 130, 130′ within the angledsidewall 144. In some examples, the tapered ring formed by the angledsidewall 144 includes a first diameter 144A at a proximal side of thetapered ring and a second diameter 144B at a distal side of the taperedring. In some examples, the first diameter 144A is smaller than thesecond diameter 144B. In other examples, the first diameter 144A issubstantially equal to the second diameter 144B. In some examples, theangled sidewall 144 provides radial compression on the valve 130, 130′.Such radial compression improves the response of the valve 130, 130′ toclose upon removal of an insertable device from the valve 130, 130′.

In some examples, the angled sidewall is at an angle A from vertical inthe range of 0 degrees to 45 degrees. In some examples, the angle A ofthe angled sidewall 144 is angled at about 10 degrees from vertical.With the valve 130, 130′ disposed within the angled sidewall 144, insome examples, the angled sidewall 144 causes the valve 130, 130′ todeform into a substantially concave shape when viewed from a proximalside (see FIG. 1D). That is, a center of the valve 130, 130′ extendsmore distally than an outside edge of the valve 130, 130′. In otherexamples, the angled sidewall 144 can be configured to cause the valve130, 130′ to deform the valve 130, 130′ into a substantially convexshape when viewed from the proximal side. For instance, in order toachieve a substantially convex shape of the valve 130, 130′ when viewedfrom a proximal side, the angled sidewall 144 can be configured suchthat the first diameter 144A is larger than the second diameter 144B. Instill further examples, the angled sidewall 144 can be configured tocause the valve 130, 130′ to remain substantially flat rather thanforming a concave shape or a convex shape when viewed from the proximalside. For instance, in order to achieve a substantially flat shape ofthe valve 130, 130′, the angled sidewall 144 can be configured such thatthe angle A from vertical is substantially 0 degrees.

In some examples, with the angled sidewall 144 included with the cap140, the valve 130, 130′ can be placed and retained within the cap 144prior to attaching the cap 140 to the hub housing 120. In some examples,the angled sidewall can be included with the hub housing 120, in whichcase, the valve 130, 130′ can be inserted within the angled sidewall ofthe hub housing 120 prior to attachment of the cap 140 to the hubhousing 120. In some examples, with the cap 140 attached to the hubhousing 120, the valve 130, 130′ is compressed between the cap 140 andthe hub housing 120 to aid in retaining the valve 130, 130′ in placewithin the medical device 100. For instance, retention of the valve 130,130′ within the angled sidewall 144 and/or compression of the valve 130,130′ between the cap 140 and the hub housing 120 can aid in retainingthe valve 130, 130′ in place within the medical device 100 while theinsertable device is passed through the valve 130, 130′; while theinsertable device is manipulated, positioned, or otherwise used withinthe patient; and/or while the insertable device is removed from thepatient, the valve 130, 130′, and/or the medical device 100. In someexamples, insertion of the insertable device through the valve 130, 130′can cause a distally-directed force on the valve 130, 130′, which, inturn, can tend to pull the outer edge of the valve 130, 130′ toward thecenter of the valve 130, 130′. By compressing the valve 130, 130′between the cap 140 and the hub housing 120, in some examples, the outeredge of the valve 130, 130′ can be inhibited from pulling away from theangled sidewall 144 and toward the center of the valve 130, 130′,thereby maintaining the valve 130, 130′ in place within the medicaldevice 100.

In some examples, the hub housing 120 includes a tooth 128 (FIG. 1D) orother projection extending from a surface of the hub housing 120 andconfigured to bear into the valve 130, 130′ with compression of thevalve 130, 130′ between the cap 140 and the hub housing 120. In thisway, a stress concentration is created in the valve 130, 130′ to aid inretaining the valve 130, 130′ in position within the medical device 100.In some examples, the tooth 128 is annularly-shaped, extending aroundthe entire passage 122 of the hub housing 120. In other examples, thetooth 128 can be made up of two or more discrete segments extendingaround the passage 122 of the hub housing 120. Although the tooth 128 isshown as being substantially triangular in shape in cross section, inother examples, other cross-sectional shapes of the tooth 128 arecontemplated, including, but not limited to, rectangular, rounded,saw-tooth-patterned, or the like. Although the tooth 128 is shownextending from the hub housing 120, in other examples, it iscontemplated that the tooth extends from the cap 140. Such aconfiguration, in some examples, can be particularly well-suited for usewith the valve deformed into the substantially convex shape when viewedfrom the proximal side. In further examples, each of the hub housing 120and the cap 140 can include a tooth or other protrusion to increasecompression of the valve 130, 130′ between the cap 140 and the hubhousing 120 and aid in maintaining the valve 130, 130′ in positionwithin the medical device 100.

In some examples, the cap 140 is attached to the hub housing 120. Insome examples, the cap 140 is attached to the hub housing 120 in amanner to inhibit the removal of the cap 140 from the hub housing,thereby helping to maintain the integrity of the medical device 100 andthe fitness of the medical device 100 for use, for instance, in aprocedure. In some examples, the cap 140 can be welded to the hubhousing 120. In further examples, the cap 140 can be sonically welded tothe hub housing 120. In various other examples, the cap 140 can beattached to the hub housing 120 in various other ways, including, butnot limited to, the cap 140 being frictionally engaged, snap fit,adhesively attached, and/or attached using one or more fasteners to thehub housing 120.

In some examples, the medical device 100 provides a complete seal aroundthe valve 130, 130′. That is, in some examples, the cap 140 is attachedto the hub housing 120 (in some examples, by sonic welding, althoughother methods of attachment are contemplated herein) with the valve 130,130′ compressed within the angled sidewall 144, thereby axiallycompressing the valve 130, 130′ between the cap 140 and the hub housing120. The tooth 128, in some examples, provides a concentrated axialforce against the bottom of the valve 130, 130′. In this way, the radialcompression of the valve 130, 130′ provided by the angled sidewall 144,the axial compression of the valve 130, 130′ caused by the attachment ofthe cap 140 to the hub housing 120, and/or the concentrated axial forceon the bottom of the valve 130, 130′ provided by the tooth 128contribute to providing a hemostatic seal for the medical device 100.

Referring to FIGS. 3A-3C, in some examples, the medical device 100 caninclude the valve 130 disposed within the medical device 100 (see FIGS.1A-1D). In some examples, the valve 130 includes a shape complementaryto the shape of the angled sidewall 144 within which the valve 130 is tobe disposed. In some examples, the valve 130 includes a substantiallycircular shape when viewed from above or below. However, the shape ofthe valve 130 is not intended to be limiting and the valve 130 can takeother shapes provided the valve 130 is capable of fitting and properlyfunctioning within the medical device 100. In some examples, the valve130 includes at least one slit 132A within the valve 130. In someexamples, the slit 132A extends from a first proximal side 130A of thevalve 130 to a second distal side 130B of the valve 130. In someexamples, the slit 132A is angularly rotated within the valve 130 fromthe first proximal side 130A to the second distal side 130B. That is,the slit 132A begins on the first proximal side 130A of the valve 130 ata first angular position with respect to the valve 130 and ends on thesecond distal side 130B of the valve 130 at a second angular positionthat is different from the first angular position. As seen in FIG. 3A,one end of the slit 132A is rotationally offset from the other end ofthe slit 132A. Stated in another way, in some examples, the one or moreslits 132A of the valve 130 are spirally disposed within the valve 130.In other examples, however, it is contemplated that the one or moreslits include no angular rotation, such that the one or more slits passstraight through the valve.

In some examples, the valve 130 includes two or more slits 132A, 132Bwithin the valve 130. In further examples, each of the at least twoslits 132A, 132B is angularly rotated within the valve 130 from one endof the slit 132A, 132B to the other end of the slit 132A, 132B. In someexamples, the at least two slits 132A, 132B intersect. In furtherexamples, the at least two slits 132A, 132B intersect at a center of thevalve 130. In other examples, it is contemplated the at least two slitsintersect in a location within the valve other than the center of thevalve. In further examples, the valve 130 includes a third slit 132C inaddition to the slits 132A, 132B. In some examples, each of the slits132A, 132B, 132C is angularly rotated within the valve 130 from one endof the slit 132A, 132B, 132C to the other end of the slit 132A, 132B,132C. In some examples, the slits 132A, 132B, 132C intersect. In furtherexamples, the slits 132A, 132B, 132C intersect at a center of the valve130. In other examples, it is contemplated that the slits intersect in alocation within the valve other than the center of the valve. In stillfurther examples, it is contemplated that the valve includes more thanthree slits. The number of slits included in the valve can depend onvarious factors including, but not limited to, pressure requirements,force needed to pass an insertable instrument through the valve, size ofthe valve, and/or material of the valve. As such, it is contemplatedthat the valve 130 includes any number of slits 132A, 132B, 132C,provided the valve 130 is capable of properly functioning within themedical device 100.

Referring to FIGS. 4A-4D, in some examples, the medical device 100 caninclude the valve 130′ disposed within the medical device 100 (see FIGS.1A-1D). In some examples, the valve 130′ includes a shape complementaryto the shape of the angled sidewall 144 within which the valve 130′ isto be disposed. In some examples, the valve 130′ includes asubstantially circular shape when viewed from above or below. However,the shape of the valve 130′ is not intended to be limiting and the valve130′ can take other shapes provided the valve 130′ is capable of fittingand properly functioning within the medical device 100. In someexamples, the valve 130′ can include two or more crossed slits 132A′,132B′, each extending through at least a portion of the thickness of thevalve 130′. That is, in some examples, the valve 130′ includes a firstslit 132A′ extending partially through the valve from a first proximalside 130A′ of the valve 130′ and a second slit 132B′ extending partiallythrough the valve 130′ from a second distal side 130B′ of the valve130′. In some examples, the second slit 132B′ is angularly offset fromthe first slit 132A′. In some examples, the first slit 132A′ isangularly offset from the second slit 132B′ by substantially 90 degrees.In other examples, the first and second slits 132A′, 132B′ can beangularly offset by less than 90 degrees. In some examples, the firstand second slits 132A′, 132B′ intersect at a location 132C′ within thevalve 130 intermediate the first proximal side 130A and the seconddistal side 130B.

In various examples, various materials are contemplated for use in thevalve 130, 130′. In some examples, the valve 130, 130′ can be at leastpartially formed from an elastomer. In some examples, the valve 130,130′ can be at least partially formed from a silicone material. In someexamples, the valve 130, 130′ can be at least partially formed from ahigh consistency rubber (HCR) silicone. In further examples, thesilicone material of the valve 130, 130′ can include a liquid siliconelubricant. In some examples, the valve 130, 130′ can be formed from aliquid silicone infused HCR material. In some examples, the valve 130,130′ can include a radiopacifier additive to allow for the valve 130,130′ to include at least some radiopaque characteristics. In otherexamples, one or more other materials can be used to form the valve 130,130′ depending upon various factors, including, but not limited to,pressure differential between ambient pressure and pressure within thepatient; environmental conditions; fluid(s) involved; size of the valve130, 130′ and/or the medical device 100; thickness of the valve 130,130′; and/or type of insertable device to be passed through the valve130, 130′.

In various examples, various types of valves are contemplated for usewithin the medical device 100, including, but not limited to, the valve130 (FIGS. 3A-3C) and the valve 130′ (FIGS. 4A-4D). As such, althoughthe valves 130, 130′ are described in detail herein, it is contemplatedthat valves other than those described herein can be used within themedical device 100 and the present subject matter should not be limitedto only the medical device 100 including the valve 130, 130′ describedherein. That is, in some examples, the medical device 100 of the presentsubject matter is independent of valve design, and, more specifically,valve slit design.

Referring now to FIGS. 5A-5D, in some examples, the medical device 100′is, in many ways, substantially similar to the medical device 100described above, with substantially similar components or aspects havingthe same reference numbers as those described with respect to themedical device 100. For that reason, the following description of themedical device 100′ is limited to the differences between the medicaldevice 100 and the medical device 100′, with reference numbers ofdifferent components or aspects being denoted with a prime (′), exceptfor the valve 130′. In a similar manner to that described above withrespect to the medical device 100, either the valve 130 or the valve130′ can be used with the medical device 100′. It should be understoodthat all of the benefits and advantages described above with respect tothe medical device 100 apply equally with respect to the medical device100′.

In some examples, the medical device 100′ includes the hub 110′. In someexamples, the hub 110′ includes the hub housing 120 including thepassage 122 from the proximal end 120A of the hub housing 120 to thedistal end 120B of the hub housing 120. In some examples, the hubhousing 120 includes the side port opening 124 for attachment to thetube 172 or other conduit of the side port 170. In some examples, theside port opening 124 is fluidly coupled to the passage 122 within thehub housing 120. In some examples, the hub 110′ includes the valve 130,130′ disposed within the hub 110′. The valve 130, 130′ is configured, insome examples, to allow passage of an insertable device through thevalve 130, 130′ while inhibiting leakage of fluid from the valve 130,130′. In various examples, various insertable devices are contemplatedfor use with the medical device 100′, including, but not limited to, aguidewire, a catheter, an introducer, a sheath, a dilator, or otherinstrument, tool, or device. In some examples, a cap 140′ is engaged tothe hub housing 120. In some examples, the cap 140′ includes an opening142′ therethrough sized and shaped to allow passage of the insertabledevice through the opening 142′. In some examples, the opening 142′allows access to the passage 122 of the hub housing 120, such that, withinsertion of the insertable device through the opening 142′ of the cap140′, the insertable device can be further moved distally to enter thepassage 122 within the hub housing 120. An angled sidewall 144′, in someexamples, is disposed within the hub 110, the angled sidewall 144′ beingconfigured to retain and deform the valve 130, 130′ into a curved shape.

In some examples, the cap 140′ and the hub housing 120 of the hub 110′are each formed from a polymeric material. In some examples, the cap140′ and the hub housing 120 can be formed from the same material,while, in other examples, the cap 140′ and the hub housing 120 can beformed from different materials. In some examples, the cap 140′ and/orthe hub housing 120 are/is formed from nylon. In other examples, the cap140′ and/or the hub housing 120 are/is formed from ABS.

Referring now to FIGS. 5A-6F, the medical device 100′ includes theangled sidewall 144′ configured to accept and retain the valve 130, 130′within the angled sidewall 144′. In some examples, the angled sidewall144′ can include discrete segments formed around the area within whichthe valve 130, 130′ is to be positioned. In other examples, the angledsidewall 144′ forms a tapered ring sized to accept the valve 130, 130′within the tapered ring. In some examples, the cap 140′ includes theangled sidewall 144′. In some examples, the angled sidewall 144′ isintegrally formed as part of the cap 140′. In other examples, the hubhousing can include the angled sidewall.

In some examples, the angled sidewall 144′ is configured to compress thevalve 130, 130′ in order to retain the valve 130, 130′ within the angledsidewall 144′, effectively pinching the valve 130, 130′ within theangled sidewall 144′. In some examples, the tapered ring formed by theangled sidewall 144′ includes a first diameter 144A′ at a proximal sideof the tapered ring and a second diameter 144B′ at a distal side of thetapered ring. In some examples, the first diameter 144A′ is smaller thanthe second diameter 144B′. In other examples, the first diameter 144A′is substantially equal to the second diameter 144B′. In some examples,the angled sidewall 144′ provides radial compression on the valve 130,130′. Such radial compression improves the response of the valve 130,130′ to close upon removal of an insertable device from the valve 130,130′.

In some examples, the angled sidewall is at an angle A′ from vertical inthe range of 0 degrees to 45 degrees. In some examples, the angle A′ ofthe angled sidewall 144′ is angled at about 10 degrees from vertical.With the valve 130, 130′ disposed within the angled sidewall 144′, insome examples, the angled sidewall 144′ causes the valve 130, 130′ todeform into a substantially concave shape when viewed from a proximalside (see FIG. 5D). That is, a center of the valve 130, 130′ extendsmore distally than an outside edge of the valve 130, 130′. In otherexamples, the angled sidewall 144′ can be configured to cause the valve130, 130′ to deform the valve 130, 130′ into a substantially convexshape when viewed from the proximal side. For instance, in order toachieve a substantially convex shape of the valve 130, 130′ when viewedfrom a proximal side, the angled sidewall 144′ can be configured suchthat the first diameter 144A′ is larger than the second diameter 144B′.In still further examples, the angled sidewall 144′ can be configured tocause the valve 130, 130′ to remain substantially flat rather thanforming a concave shape or a convex shape when viewed from the proximalside. For instance, in order to achieve a substantially flat shape ofthe valve 130, 130′, the angled sidewall 144′ can be configured suchthat the angle A′ from vertical is substantially 0 degrees.

In some examples, with the angled sidewall 144′ included with the cap140′, the valve 130, 130′ can be placed and retained within the cap 144′prior to attaching the cap 140′ to the hub housing 120. In someexamples, the angled sidewall can be included with the hub housing 120,in which case, the valve 130, 130′ can be inserted within the angledsidewall of the hub housing 120 prior to attachment of the cap 140′ tothe hub housing 120.

Referring now to FIGS. 5A-7D, in some examples, the medical device 100′includes a pressure ring 180′ disposed between the cap 140′ and thevalve 130, 130′, the pressure ring 180′ including a proximal side 180A′and a distal side 180B′. In some examples, the pressure ring 180′includes a pressure ring opening 182′ that is smaller than the opening142′ of the cap 140′. In some examples, the pressure ring 180′ isdisposed within the medical device 100′ distally with respect to the cap140′. In some examples, the pressure ring 180′ abuts a distal side ofthe cap 140′. In some examples, the pressure ring 180′ iscomplementarily shaped to fit within the cap 140′. In further examples,the pressure ring 180′ includes an outer edge 184′ sized and shaped tofit within the angled sidewall 144′ of the cap 140′. In still furtherexamples, the pressure ring 180′ includes a shoulder 186′ sized andshaped to fit within a cutout 146′ of the cap 140′. In this way, thepressure ring 180′ is sized and shaped to fit with the cap 140′ andprovide an increased surface area to abut the valve 130, 130′ within thehub 110′ of the medical device 100′. In some examples, the distal side180B′ of the pressure ring 180′ is shaped to abut the first proximalside 130A, 130A′ of the valve 130, 130′ (FIG. 5D).

In some examples, with the cap 140′ attached to the hub housing 120, thevalve 130, 130′ is compressed between the cap 140′, the pressure ring180′, and the hub housing 120 to aid in retaining the valve 130, 130′ inplace within the medical device 100′. For instance, retention of thevalve 130, 130′ within the angled sidewall 144′ and/or compression ofthe valve 130, 130′ between the pressure ring 180′ and the hub housing120 can aid in retaining the valve 130, 130′ in place within the medicaldevice 100′ while the insertable device is passed through the valve 130,130′; while the insertable device is manipulated, positioned, orotherwise used within the patient; and/or while the insertable device isremoved from the patient, the valve 130, 130′, and/or the medical device100′. In some examples, insertion of the insertable device through thevalve 130, 130′ can cause a distally-directed force on the valve 130,130′, which, in turn, can tend to pull the outer edge of the valve 130,130′ toward the center of the valve 130, 130′. By compressing the valve130, 130′ between the pressure ring 180′ and the hub housing 120, insome examples, the outer edge of the valve 130, 130′ can be inhibitedfrom pulling away from the angled sidewall 144′ and toward the center ofthe valve 130, 130′, thereby maintaining the valve 130, 130′ in placewithin the medical device 100′.

Although the examples shown and described herein are directed to aparticular configuration of the pressure ring 180′ and the cap 140′, itshould be understood that other configurations of the pressure ringand/or cap are contemplated herein. For instance, in some examples, thepressure ring and the cap can be integrally formed together. In otherexamples, the pressure ring can include a different shape than is shownand described herein, provided the pressure ring is able to fit betweenthe cap and the valve 130, 130′. For instance, in some examples, thepressure ring can be configured to fit with the cap 140 of the medicaldevice 100 of FIGS. 1A-2F. As such, the pressure ring 180′ and the cap140′ shown and described herein, and, particularly the interactionbetween the cap 140′ and the pressure ring 180′, are not intended to belimiting.

In some examples, the hub housing 120 includes the tooth 128 or otherprojection extending from a surface of the hub housing 120 andconfigured to bear into the valve 130, 130′ with compression of thevalve 130, 130′ between the cap 140′ and the hub housing 120. In thisway, a stress concentration is created in the valve 130, 130′ to aid inretaining the valve 130, 130′ in position within the medical device100′. In some examples, the tooth 128 is annularly-shaped, extendingaround the entire passage 122 of the hub housing 120. In other examples,the tooth 128 can be made up of two or more discrete segments extendingaround the passage 122 of the hub housing 120. Although the tooth 128 isshown as being substantially triangular in shape in cross section, inother examples, other cross-sectional shapes of the tooth 128 arecontemplated, including, but not limited to, rectangular, rounded,saw-tooth-patterned, or the like. Although the tooth 128 is shownextending from the hub housing 120, in other examples, it iscontemplated that the tooth extends from the cap 140′. Such aconfiguration, in some examples, can be particularly well-suited for usewith the valve deformed into the substantially convex shape when viewedfrom the proximal side. In further examples, each of the hub housing 120and the cap 140′ can include a tooth or other protrusion to increasecompression of the valve 130, 130′ between the cap 140′ and the hubhousing 120 and aid in maintaining the valve 130, 130′ in positionwithin the medical device 100′.

In some examples, the cap 140′ is attached to the hub housing 120. Insome examples, the cap 140′ is attached to the hub housing 120 in amanner to inhibit the removal of the cap 140′ from the hub housing,thereby helping to maintain the integrity of the medical device 100′ andthe fitness of the medical device 100′ for use, for instance, in aprocedure. In some examples, the cap 140′ can be welded to the hubhousing 120. In further examples, the cap 140′ can be sonically weldedto the hub housing 120. In various other examples, the cap 140′ can beattached to the hub housing 120 in various other ways, including, butnot limited to, the cap 140′ being frictionally engaged, snap fit,adhesively attached, and/or attached using one or more fasteners to thehub housing 120.

In some examples, the medical device 100′ provides a complete sealaround the valve 130, 130′. That is, in some examples, the cap 140′ isattached to the hub housing 120 (in some examples, by sonic welding,although other methods of attachment are contemplated herein) with thevalve 130, 130′ compressed within the angled sidewall 144′, therebyaxially compressing the valve 130, 130′ between the pressure ring 180′and the hub housing 120. The tooth 128, in some examples, provides aconcentrated axial force against the bottom of the valve 130, 130′. Inthis way, the radial compression of the valve 130, 130′ provided by theangled sidewall 144′, the axial compression of the valve 130, 130′between the pressure ring 180′ and the hub housing 120 caused by theattachment of the cap 140′ to the hub housing 120, and/or theconcentrated axial force on the bottom of the valve 130, 130′ providedby the tooth 128 contribute to providing a hemostatic seal for themedical device 100′. In some examples, the use of the pressure ring 180′within the medical device 100′ allows for the medical device 100′ to beused in situations with a greater pressure differential (between thepatient and the ambient pressure) with little or no leakage from thevalve 130, 130′. That is, in some examples, the medical device 100′ canbe used with little to no leakage in a situation that may cause someleakage in another similar device which does not include a pressurering. As such, in some examples, the expected pressure differential in aprocedure can lead a physician or other user to choose to use themedical device 100 over the medical device 100′ (for instance, in alower range of pressure differentials) or vice versa (for instance, in ahigher range of pressure differentials). In some examples, the medicaldevice 100, 100′ can be used for a pressure differential in the range ofabout 0 to 5 PSI. Such a range allows the medical device 100, 100′ to beused, for instance, for a radial artery of a hypertensive patient, whichcan have a pressure around 4 PSI. In some examples, the medical device100, 100′ can be used for a pressure differential in the range of about0 to at least 20 PSI. In some examples, the medical device 100′ can beused for a pressure differential above 20 PSI. In some examples, themedical device 100′ can be used for a pressure differential up to atleast 80 PSI.

In this way, in some examples, the medical device 100, 100′ can be used,for instance, to gain access to a patient's vasculature for insertion ofan insertable device therein. For instance, in some examples, themedical device 100, 100′ can be at least partially inserted within thepatient. In further examples, the sheath 160 of the medical device 100,100′ can be at least partially inserted within the patient with the hub110, 110′ remaining outside the patient. In some examples, an insertabledevice (such as, but not limited to a dilator, a guidewire, a catheter,or the like) can then be passed through the opening 142, 142′ of the cap140, 140′; the opening 182′ of the pressure ring 180′ (for the medicaldevice 100′); the valve 130, 130′; the passage 122 of the hub housing120; and the lumen 162 of the sheath 160 to enter the patient. Fromthere, the insertable device can be navigated to the desired locationwithin the patient for the particular procedure being performed. In asituation where the pressure within the patient is different than theambient pressure outside the patient (for instance, when accessing anartery of the patient where the blood pressure is higher than theambient pressure), in some examples, the valve 130, 130′ disposed andcaptured within the angled sidewall 144, 144′ of the medical device 100,100′ allows for the insertable device to be passed through the medicaldevice 100, 100′ while inhibiting, if not eliminating, spraying and/orleaking from the medical device 100, 100′.

In some examples, this limitation of spraying and/or leaking resultsfrom the configuration of the valve 130, 130′ within the medical device100, 100′, including the manner in which the valve 130, 130′ is retainedwithin the angled sidewall 144, 144′ of the medical device 100, 100′.With placement of the valve 130, 130′ within the angled sidewall 144,144′, in some examples, the angled sidewall 144, 144′ provides a radialcompression force on the slits 132A, 132B, 132C, 132A′, 132B′ of thevalve 130, 130′. Such a configuration, in some examples, allows for moreresponsive sealing of the valve 130, 130′. For instance, in someexamples, the radial compression force created in the valve 130, 130′ bythe angled sidewall 144, 144′ creates a better (for instance, quicker)response for the slits 132A, 132B, 132C, 132A′, 132B′ to close uponremoval, insertion, or other movement of an insertable device withrespect to the valve 130, 130′. The radial compression force, in someexamples, allows the slits 132A, 132B, 132C, 132A′, 132B′ to respondquicker to minimize leaking from the slits 132A, 132B, 132C, 132A′,132B′ of the valve 130, 130′.

In some examples, the angled sidewall 144, 144′ can cause the valve 130,130′ to physically bow downward (that is, the valve 130, 130′ is concavewhen viewed from the proximal side of the valve 130, 130′ within themedical device 100, 100′), which can assist with the physician or otheruser in finding the center of the slits 132A, 132B, 132C, 132A′, 132B′with insertion of the insertable device (such as, but not limited to, adilator, a catheter, a guidewire, or other instrument) through the valve130, 130′. In some examples, such a configuration allows for the valve130, 130′ to be formed or otherwise manufactured in a flat configurationand then bowed with insertion of the valve 130, 130′ within the angledsidewalls 144, 144′ of the medical device 100, 100′. In some examples,manufacturing the valve 130, 130′ in a flat orientation can simplify themanufacturing process, for instance, by eliminating the step in theprocess of forming the valve 130, 130′ into a bowed shape.

In some examples, the configuration of the angled sidewall 144, 144′ forretention of and/or radial compression on the valve 130, 130′ allows forthe valve 130, 130′ to be thinner than would otherwise be required(within a medical device having a different valve configuration, forinstance), which results in reduced insertion force for inserting theinsertable device through the valve 130, 130′. In some examples, theangled sidewall 144, 144′ allows for a surface that will always be incontact with the side of the valve 130, 130′ to better account for parttolerances. In this way, there is less impact on the performance of thevalve 130, 130′ and/or the medical device 100, 100′ with lot-to-lotvariation of the valve 130, 130′ and/or mechanical properties of thematerial(s) of the valve 130, 130′.

In some examples, the medical device 100 can be used for insertions intoan artery of the patient to allow for passage of an insertable device orother therapeutic devices through the medical device 100, 100′ and intothe artery. In some examples, the medical device 100, 100′ can be usedfor insertions into a radial artery of the patient. In some examples,the sheath 160 is at least partially inserted into the patient with thehub 110, 110′ remaining outside of the patient. In some examples, theEFEP material of the sheath 160 gives structural rigidity with a lowprofile to allow access to a location within the patient.

In some examples, the medical device 100, 100′ can be inserted into avessel of the patient, which is at a higher pressure than the ambientpressure outside of the patient. The valve 130, 130′ disposed within theangled sidewall 144, 100′ of the medical device 100, in some examples,allows for a hemostatic seal for the medical device 100, inhibiting, ifnot preventing, blood loss due to blood exiting the patient through themedical device 100, 100′. The slits 132A, 132B, 132C, 132A′, 132B′ inthe valve 130, 130′, in some examples, allow for various insertabledevices (such as, for instance, a dilator, a catheter, a guidewire, orother instrument) to be passed from outside the patient to inside thepatient. In some examples, the configuration of the medical device 100,100′ allows for better sealing around small-diameter insertable devices,such as, but not limited to, a dilator, a catheter, a guidewire, or thelike. In some examples, the configuration of the medical device 100,100′ allows for better long-term performance, including bettersealing/closing of the valve 130, 130′ after removal of an insertabledevice from the valve 130, 130′ of the medical device 100, 100′.

The present inventors have recognized various advantages of the subjectmatter described herein. The present inventors have recognized, amongother things, that the present subject matter can be used to inhibitleakage from a medical device, such as, for instance, a catheter, asheath, an introducer, or other access device. In various examples, thepresent subject matter is advantageous in that it provides increasedresponsiveness in sealing a hemostatic valve, thereby inhibitingspraying and excessive leaking from the valve. The present inventorshave recognized the present subject matter can allow for a medicaldevice including a thinner valve, thereby leading to reduced insertionforce when inserting an instrument, device, or other object through thevalve. Also, the present subject matter is advantageous in that itprovides for improved manufacturing of a medical device including ahemostatic valve. While various advantages of the example systems arelisted herein, this list is not considered to be complete, as furtheradvantages may become apparent from the description and figurespresented herein.

Although the subject matter of the present patent application has beendescribed with reference to various examples, workers skilled in the artwill recognize that changes can be made in form and detail withoutdeparting from the scope of the subject matter recited in the belowclaims.

The above Detailed Description includes references to the accompanyingdrawings, which form a part of the Detailed Description. The drawingsshow, by way of illustration, specific examples in which the presentapparatuses and methods can be practiced. These embodiments are alsoreferred to herein as “examples.”

The above Detailed Description is intended to be illustrative, and notrestrictive. For example, the above-described examples (or one or moreelements thereof) can be used in combination with each other. Otherembodiments can be used, such as by one of ordinary skill in the artupon reviewing the above description. Also, various features or elementscan be grouped together to streamline the disclosure. This should not beinterpreted as intending that an unclaimed disclosed feature isessential to any claim. Rather, inventive subject matter can lie in lessthan all features of a particular disclosed embodiment. Thus, thefollowing claims are hereby incorporated into the Detailed Description,with each claim standing on its own as a separate embodiment. The scopeof the invention should be determined with reference to the appendedclaims, along with the full scope of equivalents to which such claimsare entitled.

In this document, the terms “a” or “an” are used to include one or morethan one, independent of any other instances or usages of “at least one”or “one or more.” In this document, the term “or” is used to refer to anonexclusive or, such that “A or B” includes “A but not B,” “B but notA,” and “A and B,” unless otherwise indicated. In this document, theterms “about” and “approximately” or similar are used to refer to anamount that is nearly, almost, or in the vicinity of being equal to astated amount.

In the appended claims, the terms “including” and “in which” are used asthe plain-English equivalents of the respective terms “comprising” and“wherein.” Also, in the following claims, the terms “including” and“comprising” are open-ended, that is, an apparatus or method thatincludes elements in addition to those listed after such a term in aclaim are still deemed to fall within the scope of that claim. Moreover,in the following claims, the terms “first,” “second,” and “third,” etc.are used merely as labels, and are not intended to impose numericalrequirements on their objects.

The Abstract is provided to allow the reader to quickly ascertain thenature of the technical disclosure. It is submitted with theunderstanding that it will not be used to interpret or limit the scopeor meaning of the claims.

The invention claimed is:
 1. A hub for a medical device, the hubincluding a longitudinal axis extending from a proximal side of the hubto a distal side of the hub, the hub comprising: a hub housing includinga passage from a proximal end of the hub housing to a distal end of thehub housing; a valve disposed within the hub, the valve including acircumferential edge extending between a first proximal side of thevalve and a second distal side of the valve, the valve being configuredto allow passage of an insertable device through the valve whileinhibiting leakage of fluid from the valve; a cap engaged to the hubhousing, the cap including an opening therethrough sized and shaped toallow passage of the insertable device through the opening, the openingallowing access to the passage of the hub housing; and an angledsidewall disposed within the hub and abutting the circumferential edgeof the valve to radially compress the valve, the angled sidewall beingdisposed at an angle other than parallel to the longitudinal axis of thehub housing, wherein radial compression of the valve by the angledsidewall acts to retain the valve within the hub and deform the valveinto a curved shape.
 2. The hub of claim 1, wherein the angled sidewallforms a tapered ring sized to accept the valve within the tapered ring.3. The hub of claim 2, wherein the tapered ring includes a firstdiameter at a proximal side of the tapered ring and a second diameter ata distal side of the tapered ring, the first diameter being smaller thanthe second diameter.
 4. The hub of claim 1, wherein the angled sidewallis configured to deform the valve into a substantially concave shapewhen viewed from a proximal side.
 5. The hub of claim 1, wherein the capincludes the angled sidewall.
 6. The hub of claim 1, comprising apressure ring disposed between the cap and the valve, the pressure ringincluding a pressure ring opening that is smaller than the opening ofthe cap, wherein a distal side of the pressure ring is shaped to abutthe first proximal side of the valve.
 7. The hub of claim 1 incombination with a sheath extending distally from the distal end of thehub housing, the sheath including a lumen through the sheath, the lumenbeing fluidly coupled to the passage of the hub housing.
 8. The hub ofclaim 7, wherein the sheath is at least partially formed from EFEP. 9.The hub of claim 7, wherein the sheath is overmolded with the hubhousing.
 10. A medical device comprising: a hub including a longitudinalaxis extending from a proximal side of the hub to a distal side of thehub, the hub including: a hub housing including a passage from aproximal end of the hub housing to a distal end of the hub housing; avalve disposed within the hub, the valve including a circumferentialedge extending between a first proximal side of the valve and a seconddistal side of the valve, the valve being configured to allow passage ofan insertable device through the valve while inhibiting leakage of fluidfrom the valve; a cap engaged to the hub housing, the cap including anopening therethrough sized and shaped to allow passage of the insertabledevice through the opening, the opening allowing access to the passageof the hub housing; and an angled sidewall disposed within the hub andabutting the circumferential edge of the valve to radially compress thevalve, the angled sidewall being disposed at an angle other thanparallel to the longitudinal axis of the hub housing, wherein the radialcompression of the valve by the angled sidewall acts to retain the valvewithin the hub and deform the valve into a curved shape; and a sheathextending distally from the distal end of the hub housing, the sheathincluding a lumen through the sheath, the lumen being fluidly coupled tothe passage of the hub housing.
 11. The medical device of claim 10,wherein the angled sidewall forms a tapered ring sized to accept thevalve within the tapered ring.
 12. The medical device of claim 11,wherein the tapered ring includes a first diameter at a proximal side ofthe tapered ring and a second diameter at a distal side of the taperedring, the first diameter being smaller than the second diameter.
 13. Themedical device of claim 10, wherein the angled sidewall is configured todeform the valve into a substantially concave shape when viewed from aproximal side.
 14. The medical device of claim 10, wherein the capincludes the angled sidewall.
 15. The medical device of claim 10,wherein the valve includes at least one slit within the valve, the slitextending from the first proximal side of the valve to the second distalside of the valve, the slit being angularly rotated within the valvefrom the first proximal side to the second distal side.
 16. The medicaldevice of claim 15, wherein the at least one slit includes at least twointersecting slits within the valve.
 17. The medical device of claim 10,wherein the valve includes: a first slit extending partially through thevalve from the first proximal side of the valve; and a second slitextending partially through the valve from the second distal side of thevalve, the second slit being angularly offset from the first slit, thefirst and second slits intersecting at a location within the valveintermediate the first proximal side and the second distal side.
 18. Themedical device of claim 10, comprising a pressure ring disposed betweenthe cap and the valve, the pressure ring including a pressure ringopening that is smaller than the opening of the cap, wherein a distalside of the pressure ring is shaped to abut a first proximal side of thevalve.
 19. The medical device of claim 10, wherein the sheath is atleast partially formed from EFEP.
 20. The medical device of claim 10,wherein the sheath is overmolded with the hub housing.